Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

Lilly

Status and phase

Completed

Phase 3

Conditions

Sepsis

Treatments

Drug: Placebo

Drug: Drotrecogin alfa (activated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604214

F1K-MC-EVDP (Other Identifier)

11940

Details and patient eligibility

About

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

Enrollment

1,696 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be 18 years or older
Must have evidence of infection
Must have systemic inflammatory response syndrome (SIRS)
Must have vasopressor-dependent septic shock

Exclusion criteria

Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
Have single organ dysfunction and recent surgery (within 30 days of study entry)
Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
Are not expected to survive 28 days given their preexisting uncorrectable medical condition